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Open Study of Intravenous Recombinant Hirudin (CGP 39393) on Platelet Function and Coagulation in Healthy Volunteers

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Summary

Ten healthy male volunteers not previously exposed to hirudin participated in an open trial to evaluate the effects on platelet function and coagulation of recombinant hirudin (rec-hirudin) CGP 39393 1 mg/kg administered intravenously as a bolus injection.

The activated partial thromboplastin time (APTT) at 90 minutes, 8 hours and 12 hours after administration, was prolonged by 2.3,1.4 and 1.3 times the baseline value, respectively. The APTT was closely correlated with the plasma concentration of rec-hirudin CGP 39393, and was doubled at plasma concentrations of about 60 nmol/L (400 ng/ml).

Ex vivo platelet aggregation stimulated by a variety of inducers (except thrombin) was not inhibited. Serum thromboxane B2 and β-thromboglobulin levels decreased 20 minutes after injection, the reduction being significant only for serum thromboxane B2.

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Authors and Affiliations

  1. Centre for Molecular and Vascular Biology, University of Leuven, Campus Gasthuisberg, Herestraat 49, B-3000, Leuven, Belgium

    Bernard Hoet, Istvan Tornai, Jozef Arnout, Jos Vermylen &  Marc Verstraete

  2. Pharma Division, Ciba-Geigy Ltd, Basel, Switzerland

    Philippe Close

Authors
  1. Bernard Hoet
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  2. Istvan Tornai
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  3. Jozef Arnout
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  4. Philippe Close
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  5. Jos Vermylen
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  6. Marc Verstraete
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Hoet, B., Tornai, I., Arnout, J. et al. Open Study of Intravenous Recombinant Hirudin (CGP 39393) on Platelet Function and Coagulation in Healthy Volunteers. Drug Invest 7, 127–133 (1994). https://doi.org/10.1007/BF03258464

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